Phase 2, Randomized, Open-Label Clinical Trials of the Efficacy and
Safety of Grazoprevir and MK-3682 (NS5B Polymerase Inhibitor) with
Either Elbasvir or MK-8408 (NS5A Inhibitor) in Patients with Chronic HCV GT1,
2 or 3 Infection (Part A of C-CREST-1 & 2)—E Grane et al.
Source: The Liver Conference - Late Breaker 15
Results and Conclusions
The study was to evaluate the safety and efficacy of all-oral therapy of grazoprevir; MK-3682, and either elbasvir or MK-8408. In Part A of 2 ongoing clinical trial of 93 genotype 1 patients (46 genotype 1a, 47 genotype 1b), 61 genotype 2 patients, and 86 genotype 3 treatment-naïve, non-cirrhotic patients. The patients were treated for eight weeks with a combination of one of the above medications as a once-a-day dose.
The Bottom Line
- The cure rates were 98% for genotype 1a (45 of 46 pts); 98% genotype 1b (46 of 47 pts). There were no treatment-related RAVs associated in the people who relapsed—good news!
- The cure rates across all three arms in genotype 2 patients was 60-71%. However, in the group that received grazoprevir/MK-3682 (450 mg)/MK-8408 regime achieved a 94% (15 of 16 patients) cure rate.
- The cure rates in genotype 3 patients were 91% (78 of 86 pts) that was comparable across all arms (86 – 95%). The cure rates were lower in the genotype 3 patients with RAVs at the start of treatment 45% (6 of 11 patients) compared to those who did not have the RAVs at the beginning of treatment 97% (72 of 74 patients). Two of the patients who relapsed acquired RAVs.
- There were no treatment discontinuations. The most common side effects were headache, fatigue, nausea, diarrhea, flatulence (gas) and insomnia.
The 8-week therapy of grazoprevir/MK-3682 (450 mg)/MK-8408 produced high cure rates in genotypes 1, 2, and 3 treatment naïve patients with mild disease.
Studies are needed in a more diverse patient population, but so far this new combination looks very encouraging.
Labels: C-CREST, grazoprevir, Merck, MK-3682, MK-8408